Diabetic Foot UlcerNCT04633642
Ultrasound Assisted Wound Debridement (UAW) Versus Standard Wound Treatment in Complicated Diabetic Foot Ulcers (DFU)
A study testing Ultrasound group and Surgical group in people with Diabetic Foot Ulcer, run by Universidad Complutense de Madrid at 2 sites in Spain.
Trial summary
The investigators aimed to elucidate the effects of UAW debridement on cellular proliferation and dermal repair in complicated diabetic foot ulcers as compared to diabetic foot ulcers receiving surgical/sharp wound debridement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- Ultrasound group and Surgical group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Nov 2017to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Male and female patients ≥18 years old
- Type 1 or type 2 diabetes with levels of HbA1c≤85.8 mmol/mol (10%) within 30 days of the beginning of the study
- Wound stages IB, IIB, ID, and IID according to the University of Texas Diabetic Wound Classification [11]
- Wound duration of 1-24 months
- Wound size between 1-30 cm2 after debridement
- Clinical picture of wounds showing mild or moderate infection, according to the criteria of the Infectious Disease Society of America Guidelines [12] and the European Wound Management Association (EWMA) [13]
- Ankle-brachial index (ABI) ≤0.9 and ankle systolic blood pressure (ASBP) ≥70mmHg, or toe systolic blood pressure (TSBP) ≥50mmHg, ABI>0.9, TSBP ≥50mmHg and toe-brachial index (TBI) ≤0.7
Who cannot join
- • Chronic renal disease or dialysis
- Non-treated osteomyelitis
- Necrotizing soft tissue infections
- Critical limb ischaemia patients with ABI≤0.5 and ASBP<70mmHg or <50mmHg
- Life expectancy <6 months due to malignant DFU
- Pregnancy and lactation
- Patients diagnosed with hepatitis or human immunodeficiency virus (HIV)
- Patients showing local or systemic conditions that may impair tissue repair
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Fancisco Javier Álvaro Afonso
Madrid, 28039
José Luis Lázaro Martínez
Madrid, 28039
About this study
Official title: Cellular Proliferation, Dermal Repair, and Microbiological Effectiveness of Ultrasound Assisted Wound Debridement (UAW) Versus Standard Wound Treatment in Complicated Diabetic Foot Ulcers (DFU): A Randomized Controlled Trial
The investigators aimed to elucidate the effects of UAW debridement on cellular proliferation and dermal repair in complicated diabetic foot ulcers as compared to diabetic foot ulcers receiving surgical/sharp wound debridement. A randomized controlled trial was performed involving outpatients with complicated diabetic foot ulcers that either received surgical debridement or UAW debridement every week during a six-week treatment period.
Read the detailed description
- Methods
2.1. Trial design
A randomized and controlled parallel clinical trial was performed involving outpatients with complicated DFU that were admitted to specialized diabetic foot unit between November 2017 to December 2019. The study protocol received full approval from the Ethics Committee of the Hospital Clínico San Carlos, Madrid, Spain (C.P. - C.I. 16/484-P). Each patient provided written informed consent before inclusion.
2.1. Intervention
Participants were randomized and assigned to receive either surgical debridement or UAW debridement every week during a six-week treatment period.
Soft tissue punch biopsies (3mm) were taken after wound debridement sessions at week zero and week six.
2.2. Follow-up Patients were followed-up for 6 months after inclusion. During the follow-up period, the investigators recorded ulcer healing. Ulcer healing was defined as complete epithelialization without any sustained drainage up to 24 weeks after the end of the study follow-up.
2.3. Sample size The sample size was calculated using the Granmo v.12 program (Municipal Institute of Medical Research, Barcelona, Spain) (https://www.imim.cat/ofertadeserveis/software-public/granmo/ ). Therefore, we analyzed 51 patients (24 in surgical group and 27 en UAW group) with an alpha of 0.05 and a statistical power of 0.80.
2.4. Randomization A computer-generated random number table was used to carry out the randomization of the patients into the two groups by an investigator who was blinded to the identity of the participants.
2.5. Blinding None of the participants, care providers, and outcome adjudicators was blinded to the interventions after assignment.
2.6. Statistical Analysis Statistical analysis was performed using SPSS for IOs version 21.0 (SPSS, Inc. Chicago, IL, USA). The assumption of normality of all continuous variables was verified using the Kolmogorov-Smirnov test. Statistical differences between groups were calculated using the Chi-Square test and, where appropriate, Fisher's exact test for categorical variables. The Mann-Whitney U test was performed for abnormally distributed quantitative parameters, and Student's t-test was performed for quantitative variables that were distributed normally. The criteria of p < 0.05 was accepted as statistically significant with a confidence interval of 95%.
This study was conducted in accordance with the Declaration of Helsinki (2013 revision) and followed all local laws and regulations in clinical research investigations in patients.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- Ultrasound group, Surgical group
- Keywords
- ultrasound assisted wound debridement, surgical debridement, cellular proliferation, microbiology, diabetic foot ulcers
- Medical subject headings
- Diabetic Foot, Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound groupProcedure or surgery
Every week during a six-week treatment period
Surgical groupProcedure or surgery
Every week during a six-week treatment period
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound Group (UAW group) | Experimental | UAW debridement was performed using an UAW SONOCA 185 device (Söring GmbH, Germany). The UAW device generates an ultrasound low frequency of 25kHz and is equipped with three UAW instruments with different sonotrode shapes. The choice of sonotrode depends on wound depth, which ranges from superficial to deep. The UAW instrument piezoelectrically transforms the electrical energy delivered from the UAW device into mechanical oscillations in the sonotrode tip. For most wounds in the UAW group, a two-minute treatment with 40% intensity was performed by holding the sonotrode in contact mode, holding it perpendicular to the wound bed and moving it across in an up-and-down pattern. Receives: Procedure: Ultrasound group |
| Surgical group | Active comparator | All debridement procedures were performed by the same surgeon (J.L.M.), who is specialist in diabetic foot surgery with more than 20 years of experience.
Surgical debridement involved removal of all necrotic and devitalized tissue that was incompatible with healing, as well as surrounding callus. Receives: Procedure: Surgical group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline Neo-angiogenesis (Microvessel Density) at 6 Weeks
Sections of tissue were immunohistochemically-stained with the CD31 marker. Light microscopy was used to count the number of microvessels/endothelial cells in a standardized grid, with the results expressed as microvessel density (Leica DMD 800 morphometric system). Microvessel density was scored according to the following scale: 0 (absent), 1 (low, at least one microvessel), 2 (moderate) and 3 (more than two micro vessels).
Higher scores mean a better outcome
Measured: At week zero and week 6
Change From Baseline Collagen Formation (Collagen Content ) at 6 Weeks
Massons's trichome staining was used to differentiate collagen content from other components, such as muscle fibrin and erythrocytes, in tissue samples. Collagen content was scored according to the following scale: 0 (absent), 1 (mild), 2 (moderate) and 3 (severe). Higher scores mean a better outcome.
Measured: At week zero and week 6
Change From Baseline Myofibroblasts Formation (Myofibroblasts Content) at 6 Weeks
Actin staining was used to evaluate the presence of myofibroblasts involved in wound healing. These cells increase in number during wound healing. The number of stained cells was semi-quantitatively analyzed using a 0 - 3 scaling score (0= no myofibroblasts, 1= myofibroblasts in low quantity, 2= myofibroblasts in moderate quantity, 3= myofibroblasts in high quantity)
Measured: At week zero and week 6
Secondary outcomes (3)
Comparison of Quantitative Microbiological Analysis (Bacterial Counts Expressed Colony-forming Units Per Gram of Tissue) (CFU/g)
Tissue samples were weighed and mechanically homogenised in 0.5ml volumes of sterile phosphate buffered saline (PBS, Sigma Aldrich, St Louis, MO). Homogenates were diluted and plated onto Columbia agar (BD, Sparks, MD), Columbia agar supplemented with colistin and nalidixic acid (BD), MacConkey agar (BD), and Sabouraud dextrose agar (BD) using a spiral plater workstation (Don Whitley Scientific, Shipley, UK).The limit of detection was 10 colony-forming units (CFU). Results were expressed as CFU per gram of tissue (CFU/g). Isolated microorganisms were identified by standard criteria and the BBL Crystal identification system (BD). Susceptibility testing of Staphylococcus aureus isolates for oxacillin was performed according to Clinical and Laboratory Standards Institute (CLSI) guidelines, using a 30g cefoxitin disc and Mueller-Hinton agar .
Measured: At week zero and week 6
Wound Score at 6 Weeks
Wound bed tissue was evaluated for presence, quality, and consistency of granulation tissue using a validated wound scoring system, with scores ranging between a minimum of zero points and maximum of seven points. Higher scores mean a better outcome.
Measured: Six weeks
Wound Size
A planimetric measurements of wound size were conducted using Visitrak (Smith \& Nephew, Hull, UK), with the area of the lesion determined with an approximation of ±5mm2
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start1 Nov 2017
- Primary completion1 Nov 2018
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized and controlled parallel clinical trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Francisco Javier Álvaro Afonso, David Sevillano Fernández, Yolanda García Álvarez, Irene Sanz Corbalan, Esther García Morales
- Responsible party
- Principal investigator, Jose Luis Lazaro Martinez, Universidad Complutense de Madrid
- Investigators
- Lázaro Martinez, Professor, Principal investigator, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04633642
- Sponsor's protocol ID
- C.P. - C.I. 16/484-P
- Status last verified
- Jun 2021
- First submitted
- 30 Oct 2020
- Last updated
- 14 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schaper NC, van Netten JJ, Apelqvist J, Bus SA, Hinchliffe RJ, Lipsky BA; IWGDF Editorial Board. Practical Guidelines on the prevention and management of diabetic foot disease (IWGDF 2019 update). Diabetes Metab Res Rev. 2020 Mar;36 Suppl 1:e3266. doi: 10.1002/dmrr.3266.
PubMed 32176447Kim PJ, Steinberg JS. Wound care: biofilm and its impact on the latest treatment modalities for ulcerations of the diabetic foot. Semin Vasc Surg. 2012 Jun;25(2):70-4. doi: 10.1053/j.semvascsurg.2012.04.008.
PubMed 22817855Kingsley A, Lewis T, White R. Debridement and wound biofilms. J Wound Care. 2011 Jun;20(6):286. No abstract available.
PubMed 21739682Swanson T, Lazaro-Martinez JL, Braumann C, Kirchhoff JB, Gachter B, van Acker K. Ultrasonic-assisted wound debridement: report from a closed panel meeting. J Wound Care. 2020 Feb 2;29(2):128-135. doi: 10.12968/jowc.2020.29.2.128.
PubMed 32058848Rayman G, Vas P, Dhatariya K, Driver V, Hartemann A, Londahl M, Piaggesi A, Apelqvist J, Attinger C, Game F; International Working Group on the Diabetic Foot (IWGDF). Guidelines on use of interventions to enhance healing of chronic foot ulcers in diabetes (IWGDF 2019 update). Diabetes Metab Res Rev. 2020 Mar;36 Suppl 1:e3283. doi: 10.1002/dmrr.3283.
PubMed 32176450Lazaro-Martinez JL, Alvaro-Afonso FJ, Garcia-Alvarez Y, Molines-Barroso RJ, Garcia-Morales E, Sevillano-Fernandez D. Ultrasound-assisted debridement of neuroischaemic diabetic foot ulcers, clinical and microbiological effects: a case series. J Wound Care. 2018 May 2;27(5):278-286. doi: 10.12968/jowc.2018.27.5.278.
PubMed 29738301Altland OD, Dalecki D, Suchkova VN, Francis CW. Low-intensity ultrasound increases endothelial cell nitric oxide synthase activity and nitric oxide synthesis. J Thromb Haemost. 2004 Apr;2(4):637-43. doi: 10.1111/j.1538-7836.2004.00655.x.
PubMed 15102020Driver VR, Yao M. Discussion. Current status of the use of modalities in wound care: electrical stimulation and ultrasound therapy. Plast Reconstr Surg. 2011 Jan;127 Suppl 1:103S-104S. doi: 10.1097/PRS.0b013e3182050c35. No abstract available.
PubMed 21200279Ennis WJ, Foremann P, Mozen N, Massey J, Conner-Kerr T, Meneses P. Ultrasound therapy for recalcitrant diabetic foot ulcers: results of a randomized, double-blind, controlled, multicenter study. Ostomy Wound Manage. 2005 Aug;51(8):24-39.
PubMed 16234574Driver VR, Yao M, Miller CJ. Noncontact low-frequency ultrasound therapy in the treatment of chronic wounds: a meta-analysis. Wound Repair Regen. 2011 Jul-Aug;19(4):475-80. doi: 10.1111/j.1524-475X.2011.00701.x. Epub 2011 Jun 7.
PubMed 21649783Armstrong DG, Lavery LA, Harkless LB. Validation of a diabetic wound classification system. The contribution of depth, infection, and ischemia to risk of amputation. Diabetes Care. 1998 May;21(5):855-9. doi: 10.2337/diacare.21.5.855.
PubMed 9589255Lipsky BA, Berendt AR, Cornia PB, Pile JC, Peters EJ, Armstrong DG, Deery HG, Embil JM, Joseph WS, Karchmer AW, Pinzur MS, Senneville E; Infectious Diseases Society of America. 2012 Infectious Diseases Society of America clinical practice guideline for the diagnosis and treatment of diabetic foot infections. Clin Infect Dis. 2012 Jun;54(12):e132-73. doi: 10.1093/cid/cis346.
PubMed 22619242Boulton AJ, Armstrong DG, Albert SF, Frykberg RG, Hellman R, Kirkman MS, Lavery LA, Lemaster JW, Mills JL Sr, Mueller MJ, Sheehan P, Wukich DK; American Diabetes Association; American Association of Clinical Endocrinologists. Comprehensive foot examination and risk assessment: a report of the task force of the foot care interest group of the American Diabetes Association, with endorsement by the American Association of Clinical Endocrinologists. Diabetes Care. 2008 Aug;31(8):1679-85. doi: 10.2337/dc08-9021. No abstract available.
PubMed 18663232Tan T, Shaw EJ, Siddiqui F, Kandaswamy P, Barry PW, Baker M; Guideline Development Group. Inpatient management of diabetic foot problems: summary of NICE guidance. BMJ. 2011 Mar 23;342:d1280. doi: 10.1136/bmj.d1280. No abstract available.
PubMed 21430002Bus SA, Armstrong DG, Gooday C, Jarl G, Caravaggi C, Viswanathan V, Lazzarini PA; International Working Group on the Diabetic Foot (IWGDF). Guidelines on offloading foot ulcers in persons with diabetes (IWGDF 2019 update). Diabetes Metab Res Rev. 2020 Mar;36 Suppl 1:e3274. doi: 10.1002/dmrr.3274.
PubMed 32176441
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cellular Proliferation, Dermal Repair, and Microbiological Effectiveness of Ultrasound Assisted Wound Debridement (UAW) Versus Standard Wound Treatment in Complicated Diabetic Foot Ulcers (DFU): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04633642
- Acronym / sponsor ID
- C.P. - C.I. 16/484-P
- Conditions
- Diabetic Foot Ulcer
- Keywords
- ultrasound assisted wound debridement, surgical debridement, cellular proliferation, microbiology, diabetic foot ulcers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Collaborators
- Francisco Javier Álvaro Afonso, David Sevillano Fernández, Yolanda García Álvarez, Irene Sanz Corbalan, Esther García Morales
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 18 Nov 2020 (actual)
- Results
- Posted 14 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators aimed to elucidate the effects of UAW debridement on cellular proliferation and dermal repair in complicated diabetic foot ulcers as compared to diabetic foot ulcers receiving surgical/sharp wound debridement. A randomized controlled trial was performed involving outpatients with complicated diabetic foot ulcers that either received surgical debridement or UAW debridement every week during a six-week treatment period.
Detailed description
- Methods
2.1. Trial design
A randomized and controlled parallel clinical trial was performed involving outpatients with complicated DFU that were admitted to specialized diabetic foot unit between November 2017 to December 2019. The study protocol received full approval from the Ethics Committee of the Hospital Clínico San Carlos, Madrid, Spain (C.P. - C.I. 16/484-P). Each patient provided written informed consent before inclusion.
2.1. Intervention
Participants were randomized and assigned to receive either surgical debridement or UAW debridement every week during a six-week treatment period.
Soft tissue punch biopsies (3mm) were taken after wound debridement sessions at week zero and week six.
2.2. Follow-up Patients were followed-up for 6 months after inclusion. During the follow-up period, the investigators recorded ulcer healing. Ulcer healing was defined as complete epithelialization without any sustained drainage up to 24 weeks after the end of the study follow-up.
2.3. Sample size The sample size was calculated using the Granmo v.12 program (Municipal Institute of Medical Research, Barcelona, Spain) (https://www.imim.cat/ofertadeserveis/software-public/granmo/ ). Therefore, we analyzed 51 patients (24 in surgical group and 27 en UAW group) with an alpha of 0.05 and a statistical power of 0.80.
2.4. Randomization A computer-generated random number table was used to carry out the randomization of the patients into the two groups by an investigator who was blinded to the identity of the participants.
2.5. Blinding None of the participants, care providers, and outcome adjudicators was blinded to the interventions after assignment.
2.6. Statistical Analysis Statistical analysis was performed using SPSS for IOs version 21.0 (SPSS, Inc. Chicago, IL, USA). The assumption of normality of all continuous variables was verified using the Kolmogorov-Smirnov test. Statistical differences between groups were calculated using the Chi-Square test and, where appropriate, Fisher's exact test for categorical variables. The Mann-Whitney U test was performed for abnormally distributed quantitative parameters, and Student's t-test was performed for quantitative variables that were distributed normally. The criteria of p < 0.05 was accepted as statistically significant with a confidence interval of 95%.
This study was conducted in accordance with the Declaration of Helsinki (2013 revision) and followed all local laws and regulations in clinical research investigations in patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A randomized and controlled parallel clinical trial
| Arm | Type | Receives |
|---|---|---|
| Ultrasound Group (UAW group) | Experimental | Procedure: Ultrasound groupUAW debridement was performed using an UAW SONOCA 185 device (Söring GmbH, Germany). The UAW device generates an ultrasound low frequency of 25kHz and is equipped with three UAW instruments with different sonotrode shapes. The choice of sonotrode depends on wound depth, which ranges from superficial to deep. The UAW instrument piezoelectrically transforms the electrical energy delivered from the UAW device into mechanical oscillations in the sonotrode tip. For most wounds in the UAW group, a two-minute treatment with 40% intensity was performed by holding the sonotrode in contact mode, holding it perpendicular to the wound bed and moving it across in an up-and-down pattern. |
| Surgical group | Active comparator | Procedure: Surgical groupAll debridement procedures were performed by the same surgeon (J.L.M.), who is specialist in diabetic foot surgery with more than 20 years of experience. Surgical debridement involved removal of all necrotic and devitalized tissue that was incompatible with healing, as well as surrounding callus. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- • Male and female patients ≥18 years old
Key exclusion criteria (8 listed)
- • Chronic renal disease or dialysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound groupEvery week during a six-week treatment period | Procedure or surgery | Ultrasound Group (UAW group) |
| Surgical groupEvery week during a six-week treatment period | Procedure or surgery | Surgical group |
Primary outcome
Change From Baseline Neo-angiogenesis (Microvessel Density) at 6 Weeks
Time frame: At week zero and week 6
Sections of tissue were immunohistochemically-stained with the CD31 marker. Light microscopy was used to count the number of microvessels/endothelial cells in a standardized grid, with the results expressed as microvessel density (Leica DMD 800 morphometric system). Microvessel density was scored according to the following scale: 0 (absent), 1 (low, at least one microvessel), 2 (moderate) and 3 (more than two micro vessels). Higher scores mean a better outcome
Change From Baseline Collagen Formation (Collagen Content ) at 6 Weeks
Time frame: At week zero and week 6
Massons's trichome staining was used to differentiate collagen content from other components, such as muscle fibrin and erythrocytes, in tissue samples. Collagen content was scored according to the following scale: 0 (absent), 1 (mild), 2 (moderate) and 3 (severe). Higher scores mean a better outcome.
Change From Baseline Myofibroblasts Formation (Myofibroblasts Content) at 6 Weeks
Time frame: At week zero and week 6
Actin staining was used to evaluate the presence of myofibroblasts involved in wound healing. These cells increase in number during wound healing. The number of stained cells was semi-quantitatively analyzed using a 0 - 3 scaling score (0= no myofibroblasts, 1= myofibroblasts in low quantity, 2= myofibroblasts in moderate quantity, 3= myofibroblasts in high quantity)
3 secondary outcomes
Comparison of Quantitative Microbiological Analysis (Bacterial Counts Expressed Colony-forming Units Per Gram of Tissue) (CFU/g)
Time frame: At week zero and week 6
Wound Score at 6 Weeks
Time frame: Six weeks
Wound Size
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 32176447Schaper NC, van Netten JJ, Apelqvist J, Bus SA, Hinchliffe RJ, Lipsky BA; IWGDF Editorial Board. Practical Guidelines on the prevention and management of diabetic foot disease (IWGDF 2019 update). Diabetes Metab Res Rev. 2020 Mar;36 Suppl 1:e3266. doi: 10.1002/dmrr.3266.
- Background: PubMed 22817855Kim PJ, Steinberg JS. Wound care: biofilm and its impact on the latest treatment modalities for ulcerations of the diabetic foot. Semin Vasc Surg. 2012 Jun;25(2):70-4. doi: 10.1053/j.semvascsurg.2012.04.008.
- Background: PubMed 21739682Kingsley A, Lewis T, White R. Debridement and wound biofilms. J Wound Care. 2011 Jun;20(6):286. No abstract available.
- Background: PubMed 32058848Swanson T, Lazaro-Martinez JL, Braumann C, Kirchhoff JB, Gachter B, van Acker K. Ultrasonic-assisted wound debridement: report from a closed panel meeting. J Wound Care. 2020 Feb 2;29(2):128-135. doi: 10.12968/jowc.2020.29.2.128.
- Background: PubMed 32176450Rayman G, Vas P, Dhatariya K, Driver V, Hartemann A, Londahl M, Piaggesi A, Apelqvist J, Attinger C, Game F; International Working Group on the Diabetic Foot (IWGDF). Guidelines on use of interventions to enhance healing of chronic foot ulcers in diabetes (IWGDF 2019 update). Diabetes Metab Res Rev. 2020 Mar;36 Suppl 1:e3283. doi: 10.1002/dmrr.3283.
- Background: PubMed 29738301Lazaro-Martinez JL, Alvaro-Afonso FJ, Garcia-Alvarez Y, Molines-Barroso RJ, Garcia-Morales E, Sevillano-Fernandez D. Ultrasound-assisted debridement of neuroischaemic diabetic foot ulcers, clinical and microbiological effects: a case series. J Wound Care. 2018 May 2;27(5):278-286. doi: 10.12968/jowc.2018.27.5.278.
- Background: PubMed 15102020Altland OD, Dalecki D, Suchkova VN, Francis CW. Low-intensity ultrasound increases endothelial cell nitric oxide synthase activity and nitric oxide synthesis. J Thromb Haemost. 2004 Apr;2(4):637-43. doi: 10.1111/j.1538-7836.2004.00655.x.
- Background: PubMed 21200279Driver VR, Yao M. Discussion. Current status of the use of modalities in wound care: electrical stimulation and ultrasound therapy. Plast Reconstr Surg. 2011 Jan;127 Suppl 1:103S-104S. doi: 10.1097/PRS.0b013e3182050c35. No abstract available.
- Background: PubMed 16234574Ennis WJ, Foremann P, Mozen N, Massey J, Conner-Kerr T, Meneses P. Ultrasound therapy for recalcitrant diabetic foot ulcers: results of a randomized, double-blind, controlled, multicenter study. Ostomy Wound Manage. 2005 Aug;51(8):24-39.
- Background: PubMed 21649783Driver VR, Yao M, Miller CJ. Noncontact low-frequency ultrasound therapy in the treatment of chronic wounds: a meta-analysis. Wound Repair Regen. 2011 Jul-Aug;19(4):475-80. doi: 10.1111/j.1524-475X.2011.00701.x. Epub 2011 Jun 7.
- Background: PubMed 9589255Armstrong DG, Lavery LA, Harkless LB. Validation of a diabetic wound classification system. The contribution of depth, infection, and ischemia to risk of amputation. Diabetes Care. 1998 May;21(5):855-9. doi: 10.2337/diacare.21.5.855.
- Background: PubMed 22619242Lipsky BA, Berendt AR, Cornia PB, Pile JC, Peters EJ, Armstrong DG, Deery HG, Embil JM, Joseph WS, Karchmer AW, Pinzur MS, Senneville E; Infectious Diseases Society of America. 2012 Infectious Diseases Society of America clinical practice guideline for the diagnosis and treatment of diabetic foot infections. Clin Infect Dis. 2012 Jun;54(12):e132-73. doi: 10.1093/cid/cis346.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lázaro Martinez, Professor principal investigator
Universidad Complutense de Madrid
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound group and Surgical group in people with Diabetic Foot Ulcer, run by Universidad Complutense de Madrid at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline Neo-angiogenesis (Microvessel Density) at 6 Weeks (time frame: At week zero and week 6). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04633642, which also lists 26 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2021.